Wireless monitoring apparatus used in conjunction with an automated external defibrillator (AED) system for multiple patient rescue during mass casualty incidents

ABSTRACT

A Wireless Monitoring Apparatus is used in conjunction with an automated external defibrillator (AED) system for patient rescue in mass-casualty incidents. The rescuer applies the device on each patient. The wireless monitoring apparatus automatically analyzes the patient&#39;s heart rhythm and communicates with the AED system. The AED system is therefore is able to display information with regard to each patient, notifies the rescuer on actions to take and can deliver defibrillation therapy if needed.

REFERENCE TO PENDING PRIOR PATENT APPLICATION

This patent application is a continuation of prior U.S. patentapplication Ser. No. 12/722,216, now U.S. Pat. No. 8,577,475, filed Mar.11, 2010 by Kyle R. Bowers for WIRELESS MONITORING APPARATUS USED INCONJUNCTION WITH AN AUTOMATED EXTERNAL DEFIBRILLATOR (AED) SYSTEM FORMULTIPLE PATIENT RESCUE DURING MASS CASUALTY INCIDENTS, which in turnclaims benefit of prior, U.S. Provisional Patent Application Ser. No.61/209,873, filed Mar. 11, 2009 by Kyle R. Bowers for WIRELESSMONITORING APPARATUS USED IN CONJUNCTION WITH AN AUTOMATED EXTERNALDEFIBRILLATOR (AED) SYSTEM FOR MULTIPLE PATIENT RESCUE DURING MASSCASUALTY INCIDENTS.

FIELD OF THE INVENTION

This invention relates to Automated External Defibrillator (AED) Systemsin general, and more particularly to a Wireless Monitoring Apparatusused in conjunction with an Automated External Defibrillator (AED)System for multiple patient rescue.

BACKGROUND OF THE INVENTION

In mass casualty incidents such as transportation, terrorist ormilitary, rescuers must treat several patients at the same time,requiring several AEDs or a new system adapted to monitor severalpatient's vital signs at the same time and provide defibrillationtherapy when necessary. Such a system that can monitor several patientsat the same time allows a single rescuer to treat patients in a triagesituation. Such an example is a military doctor or trained individualthat must treat several soldiers after attack from an explosive device.Such an individual using a new system adapted to treat the criticallywounded soldiers may be the difference between life and death in remotelocations such as open battlefields where medical doctors and/orhospitals may be inaccessible. The system itself uses wirelesscommunications to exchange information (via transceiver) with regard tothe patient's vital signs and other relevant information. The rescuerapplies the monitoring apparatus directly to the bare skin patient'schest. The apparatus then analyzes the patient's ECG for cardiac arrest,communicates the information to the AED and the AED alerts the rescuerthat a soldier is in cardiac arrest and requires defibrillation therapy.The rescuer can then quickly provide therapy and continue monitor theother soldiers.

SUMMARY OF THE INVENTION

In the teaching of the Automated external defibrillator (AED) systemwith multiple patient wireless monitoring capability for use in masscasualty incidents, US Patent Application 20080177341, it becomes clearto the inventor that the wireless monitoring apparatus should haveadvanced features, as to make the system as a whole, lower-cost and moremarketable. Allowing the monitoring apparatus to “off-load” theautomated external defibrillator also reduces complexity, band-widthrequirements and allows an AED system which can monitor a greater numberof patients without having to increase system peripherals and computerarchitecture.

In accordance with one preferred form of the present invention, the newwireless monitoring apparatus has circuitry and a controller to analyzethe patient's ECG and other parameters by itself, eliminating the needto transmit the information in real-time to the AED for analysis. Thus,the current invention is not burdened with large amounts of data frommany different sources, leading to operating systems complexities andproblems well known by those skilled in the art.

In accordance with one preferred form of the present invention, thewireless monitoring apparatus contains a controller circuit whichoperates the device.

In accordance with one preferred form of the present invention, thecontroller circuit contains one or more microprocessors,microcontrollers, memory, and other circuitry to enable wirelessmonitoring apparatus operation.

In accordance with one preferred form of the present invention, thewireless monitoring apparatus contains circuitry to allow the apparatusto communicate wirelessly to an AED, a computer system, a wirelessnetwork or other wireless devices well known by those skilled in theart.

In accordance with one preferred form of the present invention, thewireless monitoring apparatus contains an analog-to-digital converter(A/D) and other analog or digital circuitry.

In accordance with one preferred form of the present invention, thewireless monitoring apparatus contains a battery and is self-powered.The battery contained within the apparatus may be removable, disposable,rechargeable, non-rechargeable, non-removable or any combination of theabove well known by those skilled in the art. The apparatus alsocontains circuitry which allows measurement of the battery voltageand/or temperature. The apparatus is capable of storing this informationin memory and may transmit this data other data with regard to thebattery to the AED or wireless system described previously.

In accordance with one preferred form of the present invention, thewireless monitoring apparatus contains an impedance analysis circuit todetermine if the wireless monitoring apparatus is applied to thepatient. The impedance analysis circuit may also measure thetrans-thoracic impedance of the patient storing the measurement inmemory and/or transmitting the information to the AED or other wirelesssystem described previously.

In accordance with one preferred form of the present invention, thewireless monitoring apparatus contains memory to store other informationabout the patient, such as the patient's ECG data. The wirelessmonitoring apparatus can transmit the ECG data and other relevantinformation to the AED in real-time upon request from the AED. Thisallows the rescuer to view the patient's ECG signal in real-time on thedisplay of the AED. The rescuer may also decide to view a differentwireless monitoring apparatus ECG based on the ECG of the currentapparatus.

In accordance with another preferred form of the present invention, thewireless monitoring apparatus can transmit the ECG or other data storedin memory to a computer system upon request. The computer system runs aprogram which communicates with the wireless monitoring apparatus andmay exchange, remove, download, upload or delete any form of data withthe apparatus. The computer system may be an AED or other wirelesssystem described previously.

In accordance with one preferred form of the present invention, thewireless monitoring apparatus is adapted to monitor patient parametersother than the patient's ECG or impedance, e.g., patient pulse and heartrate, patient temperature, patient blood pressure, patient blood oxygenlevel, etc. As those skilled in the art understand, the wirelessmonitoring apparatus may be adapted to communicate with any suchwireless device that may provide information about the patient's health,care, identity or any other information about the patient.

In accordance with one preferred form of the present invention, thewireless monitoring apparatus contains a release liner, that when peeledaway, activates the device and exposes the monitor electrodes. Inaccordance with another preferred form the present invention, thewireless monitoring apparatus release liner contains a component thatcauses activation of the device. As those skilled in the art canappreciate, the component may be an active or inactive device.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the present invention, whichare to be considered together with the accompanying drawings whereinlike numbers refer to like elements and further wherein:

FIG. 1 is a pictorial of one concept the new wireless monitoringapparatus attached to the patient;

FIG. 2 is a pictorial of another concept the new wireless monitoringapparatus attached to the patient;

FIG. 3 is a pictorial of yet another concept the new wireless monitoringapparatus

FIG. 4 is a block diagram showing a high-level system diagram of the newwireless monitoring apparatus;

FIG. 5 is a block diagram showing more detailed system diagram of thenew wireless monitoring apparatus system;

FIG. 6 is a flow diagram showing an example method of the wirelessmonitoring apparatus communications with the AED;

FIG. 7 is a flow diagram showing an example data flow communications tothe AED;

FIG. 8 is a pictorial of a concept the new wireless monitoring apparatusrelease liner detached;

FIGS. 9A and 9B are flow diagrams showing example methods of thewireless monitoring apparatus communication link protocol;

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In accordance with the present invention, the new wireless monitoringapparatus is a stand-alone device, capable of determining if a patientrequires therapy and alerting the rescuer of such condition. Thewireless monitoring apparatus may also communicate and work inconjunction with an AED or other monitoring device. In addition, severalwireless monitoring apparatuses may communicate and work in conjunctionwith an AED or other device to make a complete system to help a singlerescuer treat several patients in a triage situation.

FIGS. 1 and 2 show concepts of the wireless monitoring apparatus appliedto the patient. The rescuer peels off a release liner (shown in FIG. 8)that exposes the electrodes. The electrode area shown in FIG. 8 issquare, but the area may be round or any other shape. The release linercontains an “activation” component that causes the wireless monitoringapparatus to automatically power-on when the liner is removed. Theactivation component shown in FIG. 8 is a resistor. This allows anidentification of the type of monitor being used. In other words, theremay be non-clinical versions that are used for training and allow aresealing, so that the training monitor can be used multiple times. Thewireless monitoring apparatus communicates this information and allowsthe system to be put in “training mode” for specific configurations ofthe AED. Other versions of the release liner may contain simply a wireor another component. The release liner contains instructions anddiagrams that show the rescuer where to place the wireless monitoringapparatus, how to remove the liner, etc.

Although these instructions are provided, removal of the release lineris easy and intuitive; the user simply peels the pull tab shown in FIG.8 to remove the liner. In addition, the wireless monitoring apparatusneed not be located exactly as shown in the diagrams and will work inalmost any position as long as it is located around the heart.

The electrodes and surrounding pad may contain a hydrogel, electricallyconductive adhesive or other compound which serves to connect thewireless monitoring apparatus to the patient and helps to hold thedevice in place.

The wireless monitoring apparatus shown in FIGS. 1 and 2 is in Lead-Iconfiguration, but could also be adapted for Lead-II, 3-Lead or otherconfigurations as well.

Yet another concept of the wireless monitoring apparatus is shown inFIG. 3. This concept can be found in the inventor's previous teachings.However, the concepts shown in FIGS. 1 and 2 may contain features of theconcept shown in FIG. 3. Such examples of these features are straps orother retaining methods, the use of inexpensive, off-the-shelf snapelectrodes, movable electrodes, multiple electrodes, removableelectronics, etc.

A simple block diagram is shown in FIG. 4. The wireless monitoringapparatus can be broken down into six basic blocks shown in the diagram.

A more detailed block diagram of the new wireless monitoring apparatusis shown in FIG. 5. The controller circuit contains the necessarycomponents and circuits to assure the wireless monitoring apparatusworks efficiently and reliably. Such examples of these are a watch-dogcircuit which causes the indication system to warn the rescuer of amalfunction of the controller or other circuits.

In accordance with the present invention, the watch-dog circuit andstatus indication system are configured so that if either fail, thestatus indication system indicates that the device is unusable, ensuringthe entire system is failsafe.

In accordance with the present invention, the wireless monitoringapparatus runs a periodic self-test and uses the status indicationsystem to notify the user of the results. The periodic self-test checksthe wireless monitoring apparatus circuitry, controllers, batteries,etc.

The indication system contains visual and audible components to alertthe user of a number of conditions. Examples of such conditions arealerting the rescuer that the patient requires therapy or attention,locating the patient if indicated by an AED or other monitoring device,alerting the user of low battery, other conditions within the device,etc.

In accordance with the present invention, the new wireless monitoringapparatus uses a proprietary method to communicate with an AED or othertype of monitoring device. As described previously, the wirelessmonitoring apparatus powers-on when the release liner is removed, itthen begins to “search” for an AED using a communication link protocol.In accordance with the present invention, the new wireless monitoringapparatus uses programmable parameters to determine how thecommunication link is established. In FIG. 9A, the simplest protocol isused to establish a link between the wireless monitoring apparatus andan AED. In FIG. 9B, the protocol adds a unique ID which ispre-programmed into the wireless monitoring apparatus before it isplaced into service. There is therefore a match between the AED and thewireless monitoring apparatuses which are placed in service with theAED; most likely in the same carrying case of the AED, so that therescuer need not be concerned with the wireless monitoring apparatusconnecting to other AEDs placed in service. This simplifies the processin the event of a large triage situation where there are several groupsof rescuers treating specific groups of patients. In accordance with thepresent invention, the new wireless monitoring apparatus uses otherpre-programmed parameters and can easily be adapted to use newertechnologies. As those skilled in the art can appreciate, examples ofthese are using GPS to locate the nearest AED, using the AED connectedto chose the monitoring device to establish a new link with, using theAED to disconnect with the wireless monitoring apparatus, etc. and anycombination thereof. As those skilled in the art understand, the abovedecision tree blocks could easily be added to the flow diagrams in FIGS.9A and 9B. In addition, as those skilled in the art can appreciate andin accordance with the present invention, the new wireless monitoringapparatus affords the ability to first be used with an AED in any formor another device as described above and then be used with a subsequentmonitoring device. As those skilled in the art can appreciate, examplesof such subsequent devices are, but not limited to, other manufacturer'sAEDs, defibrillators, patient monitors, etc. In accordance with thepresent invention, the new wireless monitoring apparatus will work withany other device that is adapted to follow the methods described in thepresent invention. In current device technologies, USB dongles, sticks,PCMCIA, WiFi cards, etc. make adapting other manufacturer's devices towork in conjunction with the new wireless monitoring apparatus areality. This allows continuation of health care possible throughout thecomplete chain of rescue; from the initial triage situation, to thetransport of the patient to the hospital and transport within thehospital to the emergency care units.

FIG. 6 shows an example of the method of the wireless monitoringapparatus communications with an AED. In accordance with the presentinvention, the wireless monitoring apparatus immediately beginsanalyzing the patients ECG and other parameters. As described above, thewireless monitoring apparatus begins to “search” for an AED using apredetermined protocol. As shown in FIG. 6, if the wireless monitoringapparatus can not communicate with an AED or other wireless monitoringdevice for whatever reason, it can still operate in stand-alone mode andindicate to the trained user the condition of the patient and whatactions or therapies are required. In accordance with the presentinvention, the wireless monitoring apparatus indication system usesbeeps of different tones, durations, frequency or any combinationthereof. In addition, these beeps may be used in combination of one ormore flashing indicator lights.

If the wireless monitoring apparatus finds an AED, it begins to send theAED information about the patient. If the patient does not requiredefibrillation therapy, it communicates this to the AED, which promptsthe rescuer and then continues with the protocol according to AHA(American Heart Association) and/or ERC (European Resuscitation Council)guidelines. If the patient does require defibrillation therapy, then thewireless monitoring apparatus communicates that a shock is required andthe AED begins to charge the capacitors and prepares to deliver a shock.The wireless monitoring apparatus indicates the patient for the rescuerto apply the defibrillation electrodes and by the time the electrodesare applied, the AED is ready to deliver a defibrillation shock. Asthose skilled in the art can appreciate, the timeline from applicationof the wireless monitoring apparatus to the time therapy is delivered isexpedited, as taught by the present invention.

In accordance with the present invention and described above, thewireless monitoring apparatus has many modes of operation. It has becomeclear to the inventor that it is advantageous for the wirelessmonitoring apparatus to analyze the patient's ECG and other parametersitself, thereby removing the burden of transmitting the data to the AED,for the AED to analyze and then determine actions. However, inaccordance with the present invention, there are modes in which thewireless monitoring apparatus does send the ECG data in real-time to theAED. Such mode of operation is when the rescuer selects the patient'sECG to view, using a menu on the AED. The rescuer can then view thepatient's ECG in real-time on the AED's screen and determine whatactions, if any are necessary. In FIG. 7 an example method of thewireless monitoring apparatus data flow to the AED is shown. The readershould distinguish that there are two types of data flow; (1) The datais sent in real-time or “streaming” so that the rescuer can view thedata on the AED screen and (2) The data is read from internal memory andis downloaded to the AED. As those skilled in the art can appreciate,the downloading of data may be to an AED, computer or other device. Asthose skilled in the art understand and shown in FIG. 7, the wirelessmonitoring apparatus only chooses to download the data from internalmemory during non-clinical periods or after a clinical event haselapsed.

Modifications

While the present invention has been described in terms of certainexemplary preferred embodiments, it will be readily understood andappreciated by those skilled in the art that it is not so limited, andthat many additions, deletions and modifications may be made to thepreferred embodiments discussed herein without departing from the scopeof the invention.

What is claimed is:
 1. A system for patient rescue, the systemcomprising: a defibrillator comprising: a capacitor; a battery forselectively charging the capacitor; a first electrode selectivelyconnected to the capacitor for delivering a shock to a patient;defibrillator control circuitry for selectively causing (a) the batteryto charge the capacitor, and (b) the capacitor to discharge through thefirst electrode; and a first wireless communications unit connected tothe defibrillator control circuitry; and a stand-alone wireless monitorcomprising: a second electrode for attachment to a patient; a releaseliner releasably secured to the second electrode; monitor controlcircuitry connected to the release liner and to the second electrode;and a second wireless communications unit connected to the monitorcontrol circuitry; the monitor control circuitry being configured sothat when the release liner is removed from the second electrode and thesecond electrode is positioned on a patient, the monitor controlcircuitry reads the second electrode, determines whether the patient isexperiencing a shockable event and, if the patient is experiencing ashockable event, gives an audio or visual indication to a user.
 2. Asystem according to claim 1 wherein the monitor control circuitrymeasures and analyzes the patient's ECG signal.
 3. A system according toclaim 2 wherein the monitor control circuitry measures and analyzes thepatient's transthoracic impedance signal.
 4. A system according to claim3 wherein the monitor control circuitry further measures and analyzes atleast one from the group consisting of: patient temperature; patientblood oxygen level; patient blood pressure; patient pulse; and patientheart rate.
 5. A system according to claim 2 wherein the monitor controlcircuitry analyzes the patient's ECG signal to determine if thepatient's heart rhythm is shockable.
 6. A system according to claim 5wherein the monitor control circuitry determines if the patient's heartrhythm is shockable and communicates the results to an AED.
 7. A systemaccording to claim 5 wherein the monitor control circuitry determines ifthe patient's heart rhythm is shockable and uses a status indicationsystem to notify the user of the results.
 8. A system according to claim5 wherein the monitor control circuitry measures and stores patient datain internal memory.
 9. A system according to claim 5 wherein the monitorcontrol circuitry transmits patient data in real-time to another device.10. A system according to claim 8 wherein the monitor control circuitrytransmits patient data stored in internal memory to another wirelessdevice.
 11. A system according to claim 10 wherein the monitor controlcircuitry transmits patient data stored in internal memory only duringnon-clinical periods.
 12. A system according to claim 11 wherein themonitor control circuitry has a unique ID number which is transmitted toanother device.
 13. A system according to claim 1 wherein the monitorcontrol circuitry comprises an indication system having visual andaudible components to alert the user of a number of conditions.
 14. Asystem according to claim 13 wherein the monitor control circuitry runsa periodic self-test and uses the status indication system to notify theuser of the results.
 15. A system according to claim 14 wherein themonitor control circuitry contains a watch-dog circuit that works inconjunction with the status indication system, so that if any circuitmal-functions, the status indication system notifies the user in afailsafe manner.
 16. A system according to claim 15 wherein the monitorcontrol circuitry uses a communication link protocol to connect with anAED or other wireless device.
 17. A system according to claim 16 whereinthe communication link protocol uses a pre-programmed parameter todecide which device it connects with.
 18. A system according to claim 16wherein the communication link protocol uses GPS location to decidewhich device it connects with.
 19. A system according to claim 16wherein, upon request from a wireless device, the apparatus establishesa communications link.
 20. A system according to claim 16 wherein uponrequest, the monitor control circuitry changes its communications linkwith the current device to a new device.
 21. A system according to claim1 wherein the release liner contains a component that indicates that thedevice is for training use or clinical use.
 22. A system according toclaim 1 wherein removal of the release liner is sensed by the monitorcontrol circuitry and this information is communicated to an AED orother device to place it in training or clinical modes.
 23. A systemaccording to claim 1 wherein the electronics are removable.
 24. A methodfor patient rescue, the method comprising: providing a system forpatient rescue, the system comprising: a defibrillator comprising: acapacitor; a battery for selectively charging the capacitor; a firstelectrode selectively connected to the capacitor for delivering a shockto a patient; defibrillator control circuitry for selectively causing(a) the battery to charge the capacitor, and (b) the capacitor todischarge through the first electrode; and a first wirelesscommunications unit connected to the defibrillator control circuitry;and a stand-alone wireless monitor comprising: a second electrode forattachment to a patient; a release liner releasably secured to thesecond electrode; monitor control circuitry connected to the releaseliner and to the second electrode; and a second wireless communicationsunit connected to the monitor control circuitry; the monitor controlcircuitry being configured so that when the release liner is removedfrom the second electrode and the second electrode is positioned on apatient, the monitor control circuitry reads the second electrode,determines whether the patient is experiencing a shockable event and, ifthe patient is experiencing a shockable event, gives an audio or visualindication to a user; and removing the release liner from the secondelectrode and positioning the second electrode on the patient, so thatthe monitor control circuitry reads the second electrode and, determineswhether the patient is experiencing a shockable event; and if thepatient is experiencing a shockable event, giving an audio or visualindication to a user.